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Quality Assurance Engineer – Quality Systems in Clare, Ireland at Beckman Coulter Diagnostics

Date Posted: 1/8/2019

Job Snapshot

Job Description

Job ID: BEC013734

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Description

Title:                Analyst II Quality Assurance – Quality Assurance Engineer – Quality Systems
 
Level:               P2
                       
Reporting To:  Quality Systems Manager
 
 
Responsibilities
Typical responsibilities will include but are not limited to the following:
  • Support the corrective and preventative action process in BCII
  • Support process owners with review of data sources for CAPA eligibility
  • Approval of each element of CAPA actions and ensure complaint closure of CAPAs
  • Provide support and training to staff using the CAPA system
  • Provide support and training to staff participating in PAR/CI’s as well as track and trend activities associated to PAR/CI process.
  • Complete planning and preparation activities associated with BCII QSMR
  • Prepare trend analysis on areas such as CAPA, PARs, CI’s, as required
  • Participate in audits carried out by external agencies
  • Participate in the internal audit program at BCII
  • Provide site support on quality system issues to ensure adherence to ISO, FDA, CMDR, IVDD, J-PAL, BCI requirements and industry best practice.
  • Maintenance of procedures necessary for the efficient operation of the quality system e.g. SOPs and documents of external origin.
  • Participate on cross functional teams to collaborate on and improve processes that cross department boundaries
  • Represent quality systems in events, Kaizen or projects as required, lead events if required. 
  • Actively use DBS, daily management, policy deployment and lean tools to improve processes within the quality system
  • Represent quality systems on transfer projects as required
  • Provide training, support and direction to QS team members regarding QS requirements
  • Maintenance of procedures necessary for the efficient operation of the quality system
  • Support maintenance of site quality system documentation e.g. update, review, approval and tracking of standard operating procedures
  • Support the coordination of the storage offsite and the retrieval of quality records
Any other tasks requested by the quality systems manager BCII

Job Requirements



Qualifications

Education/ Experience:
  • B.Sc in chemistry, biochemistry, engineering or other relevant technical field with at least 2 years’ experience in similar/related role is required
  • A good working knowledge / understanding of ISO13485, FDA (CGMP), CMDR, MHLW, and IVDD requirements is essential. Computer literacy is essential.
  • A qualified lead auditor.
  • Excellent time management and organisation skills.
  • Effective interpersonal and verbal/written communication skills.
  • Strong proof reading skills with emphasise on attention to detail.
                 


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.